AstraZeneca struggles to regain confidence in the vaccine after PR errors

American officials and health experts are increasingly concerned that AstraZeneca shots, once considered the world’s coronavirus vaccine for its low cost and ease of storage, may already be trained on anti-vaccine rhetoric on Covid-19 shots, as record speed Is. Their development. It can be difficult to reach, especially because of the declining trust in the AstraZeneca vaccine, U.S. A small population of people who are already skeptical of the government’s inoculation campaign – not to mention people in developing countries who think they have a third or fourth best option. .

“You have a company that has the potential to have a very good vaccine, which has made every possible effort to appreciate whether it is a good vaccine or not,” said data pointing to the company’s vaccine tests and UK doses. Error and the company attempted to combine trial data from multiple dosing resins. “His whole approach … can be described, as kind, dull.”

Few would have predicted the level of suspicion and controversy that has plagued the AstraZeneca vaccine in recent months. The shot, originally developed by researchers at Oxford University, was one of the first to be placed in clinical trials. At the onset of the epidemic, AstraZeneca officials suggested that the dose could be obtained as early as October 2020, far ahead of other vaccine claimants. The Trump administration ordered 300 million doses last May, more than the initial order put in place with other vaccine manufacturers.

But then problems began: this fall, AstraZeneca suspended its trials around the world to assess a serious illness in a UK study participant, and the U.S. It took about two months for the trial to resume. It then became clear that the drug manufacturer had mistakenly given about half of the first dose to around 1,000,000 people in a UK trial – and the results were really strong for lower, erroneous doses.

This stumbling block caused U.S. Officials cautioned to accept early indications that the vaccine is safe and effective, although this year more than 50 countries have recognized and divided the shots into millions. But the U.S. Still had 300 million doses promised by AstraZeneca and were surrounded to let the shots go.

U.S. Government officials have acknowledged in conversations with Politico that the AstraZeneca vaccine is not needed to meet President Biden’s goal of vaccinating all adults until Fischer, Moderna and Johnson and Johnson deliver their promised doses. But two people familiar with the debate said production problems or the possibility of anything that could threaten Biden’s promise to get enough doses for every American by the end of May. Reluctance to skip any Astrazeneka dose from Stockpile.

The administration finally announced last week that it would give Mexico. million million doses and 1 to Canada. will give a million doses, but officials have not expressed plans to distribute more shots worldwide.

The company plans to apply for emergency use in the United States in early April, and could supply 30 million doses immediately, with 50 million more in the next few weeks if the Food and Drug Administration clears the vaccine, an AstraZeneca spokesman said. . After that, the company projects that it can supply the United States with 15 to 20 million doses per month.

“We believe our vaccine can have a definite and tangible effect during an epidemic, protecting millions of people in Europe and around the world against this deadly virus,” said an AstraZeneca spokesman. “We’re seeing successful vaccination programs around the world – and protecting populations, including the elderly, is of primary importance.”

Still, the confusion and anger surrounding AstraZeneca’s boasted global rollout is frustrating. Government officials and vaccine experts, in a similar world, cast shadows on shots that could still play a large role in global vaccination efforts.

Some experts also worry that Biden’s timing of loans to neighboring countries is sending an unwelcome message.

“The last thing you want to do is make two perceptions of people in the world: those who get good vaccines and those who get good vaccines feel less good,” said a senior Food and Drug Administration official.

Peter Hotz, a vaccine specialist at Baylor University who developed the coronavirus vaccine, shares similar concerns.

“It’s great that they send vaccines to Canada and Mexico, but at the same time all these European countries are postponing it – they have to take care of the optics here,” he said. “You’ve had a lot of bad things at once with this vaccine.”

It includes 13 European countries withdrawing recommendations to use the vaccine amid reports of blood clots that have not yet been linked to the shot; All have resumed use of the vaccine after being confirmed last week by the Blood Week Drugs Agency. There are also preliminary data from South African trials indicating that the vaccine is not effective against the prevailing strain there, B..1.351, which is why the country continues to defer the shutdown.

“And now you have the impression that the Biden administration is just dumping its dose. He’s throwing tea overboard, “Hotz said.

Europe’s mixed reaction to the vaccine is a catastrophe, especially since the U.S. And European drug regulators are generally seen as groups aligned with similarly high standards, current and former U.S. health officials said.

“The administration of the AstraZeneca vaccine is a black mark for European drug regulators,” said a senior FDA official. “This was to be done by the European Union to put all this together and do a good job for all the member countries, so that the member states could not do it independently. And what this fiasco does makes Brexit feel so good. “

Just before concerns arose last week about blood clots, some European countries began banning the use of the vaccine in the elderly, citing insufficient data in the population. Officials around the block also expressed frustration over AstraZeneca’s manufacturing delays, with some accusing the company of cutting off European orders in order to get better prices elsewhere.

In public, Biden’s top officials are rushing to improve AstraZeneca’s image. The president’s chief medical officer, Anthony Foucault, backed the European Medicines Agency’s security assurances at a White House briefing and congressional hearing, saying the incidence of blood clots in the AstraZeneca vaccine trial was similar to their frequency in the real world.

And Andy Slavit, a White House coronavirus adviser, stressed the quality of the Food and Drug Administration’s vaccine reviews during a White House press briefing Monday. “Science is what is going to happen. The result will be what happens, ”he said. “The American public will need to hear that and it’s important that they have great faith in what comes out of our independent scientific agencies.”

But it’s not clear if U.S. trial data released by AstraZeneca on Monday – which shows the vaccine is a tougher alternative to shots already authorized by the FDA – could turn the tide of public opinion around the world. African and Asian countries, including the Democratic Republic of Congo, Indonesia and Thailand, sued, citing European concerns, after countries including France, Germany, Spain and Italy suspended the use of the vaccine.

Officials at the World Health Organization have reacted by arguing behind the shot, insisting it is still in high demand among members of the global equity effort known as the COVAX facility. Bruce Alward, a WHO consultant working with the program, said all the countries in the Caucasus group were moving forward with it.

Thailand and Indonesia resumed vaccinations after a brief suspension received by the Thai prime minister last week to boost confidence, but the DRC, which has delayed the rollout of the 1.7 million doses it received from Kovex, has not yet announced plans to end its suspension. Meanwhile, South Africa has sold 1.5 million doses it received from India’s Serum Institute to 14 other African countries.

“We don’t have many options for global health,” Hotez said, noting that Pfizer and Moderna have limited global deals. “What do we have? We have Jammu and J vaccines, maybe, and then you get Russian and Chinese vaccines that have bypassed the WHO (prerequisites) so far, ”the World Health Organization refers to the process of assessing the safety and effectiveness of vaccines – a complex dilemma. Meanwhile part of his recent endorsement for AstraZeneca.

“We don’t have much for low- and middle-income countries.” And that’s why we need this. “

Carmen Page contributed to this report.